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Status:

COMPLETED

Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Adenocarcinoma

Cervical Adenosquamous Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.

Detailed Description

PRIMARY OBJECTIVE: I. Correlate progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pel...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Diagnosis of cervical cancer
  • Any histology
  • Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis
  • Meets 1 of the following stage criteria:
  • Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month
  • Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy
  • Must have received prior primary treatment, including any of the following:
  • Surgery with or without post operative radiotherapy with or without chemotherapy
  • Primary radiotherapy with or without chemotherapy
  • Neoadjuvant chemotherapy followed by surgery
  • Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy
  • Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry
  • Deemed to be a good surgical candidate
  • No evidence of distant disease or disease that is felt to be unresectable by physical examination
  • Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon
  • Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible
  • Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible
  • No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography
  • No noncervical primary tumor
  • No prior anterior or posterior pelvic exenteration

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    38 Patients enrolled

    Trial Details

    Trial ID

    NCT00217633

    Start Date

    January 1 2006

    Last Update

    May 29 2015

    Active Locations (39)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (39 locations)

    1

    University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States, 35233

    2

    Colorado Gynecologic Oncology Group

    Aurora, Colorado, United States, 80010

    3

    Hartford Hospital

    Hartford, Connecticut, United States, 06102

    4

    The Hospital of Central Connecticut

    New Britain, Connecticut, United States, 06050